Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis

Recruiting

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT06655701
• Lead Sponsor: Beylikduzu State Hospital

Brief Summary

The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.

Detailed Description

One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-23
• Study Start: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Postmenopausal women with DXA measurements performed within the last 6 months.
• Based on DXA measurements:

Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).

Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.

• Aged 50-75 years

Exclusion Criteria

• Refusal to participate in the study.
• History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
• Presence of psychiatric disorders.
• Cognitive impairments.
• Use of medications that could affect the study results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Stress Urinary Incontinence:	0 day	Stress urinary incontinence (SUI) is the involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or lifting. In this study, the presence of SUI will be determined through a questionnaire that asks participants about symptoms and frequency of urine leakage during such activities.
Incontinence Quality of Life Scale (I-QOL):	0 day	The I-QOL is a validated questionnaire that measures the impact of urinary incontinence on a patient's quality of life. It assesses how incontinence affects daily activities, social interactions, and emotional well-being. Higher scores indicate better quality of life, while lower scores suggest that incontinence has a more significant negative impact on the patient's day-to-day functioning.
Skeletal Muscle Mass:	0 day	Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.
Handgrip Strength	0 day	This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.

Trial Locations

Locations (1)

Beylikdüzü State Hospital; 🇹🇷 Istanbul, Turkey